3.2.2.1. PLASTIC CONTAINERS FOR - uspbpep.com

1 EUROPEAN PHARMACOPOEIA Sterile PLASTIC CONTAINERS for human bloodFor the results of the testing on type samples to remain valid,it is important that: there is no change in the composition of the material asdefinedforthetypesamples, there is no change in the manufacturing process asdefined for the type samples, especially as regards thetemperatures to which the PLASTIC material is exposedduring conversion or subsequent procedures such assterilisation, scrap material is not of excess material of well-defined nature andproportions may be permitted after appropriate to satisfactory testing for compatibility of eachdifferent combination of container and contents.

2 Thematerials described in the Pharmacopoeia are recognised asbeing suitable for the specific purposes indicated, as :90003corrected PLASTIC CONTAINERS FORAQUEOUS SOLUTIONS FOR INFUSIONDEFINITIONP lastic CONTAINERS for aqueous solutions for infusion aremanufactured from one or more polymers, if necessarywith additives. The CONTAINERS described in this sectionare not necessarily suitable for emulsions. The polymersmost commonly used are polyethylene, polypropylene andpoly(vinyl chloride). The specificationsofthistextaretoberead in conjunction with PLASTIC containersand closures for pharmaceutical for the attachment of an infusion set designed toensure a secure connection.

3 They may have a site that allowsan injection to be made at the time of use. They usuallyhaveapartthatallowsthemtobesuspen dedandwhichwillwithstand the tension occurring during use. The containersmust withstand the sterilisation conditions to which they willbe submitted. The design of the container and the method ofsterilisation chosen are such that all parts of the containersthat may be in contact with the infusion are sterilised. Thecontainers are impermeable to micro-organisms after CONTAINERS are such that after filling they are resistantto damage from accidental freezing which may occur duringtransport of the final preparation.

4 The CONTAINERS are andremain sufficiently transparent to allow the appearance ofthecontentstobeexaminedatanytime,unles sotherwisejustified and empty CONTAINERS display no defects that may lead toleakage and the filled and closed CONTAINERS show no satisfactory storage of some preparations, the containerhas to be enclosed in a protective envelope. The initialevaluation of storage has then to be carried out using thecontainer enclosed in the solution S within 4 h of to its nominal capacity withwater Rand close it, ifpossible using the usual means of closure; otherwise closeusing a sheet of pure aluminium.

5 Heat in an autoclave sothat a temperature of 121 2 C is reached within 20 minto 30 min and maintain at this temperature for 30 min. Ifheating at 121 C leads to deterioration of the container ,heat at 100 C for 2 Prepare a blank by heatingwater Rin aborosilicate-glass flask closed by a sheet of pure aluminiumatthetemperatureandforthetimeus edforthepreparationof solution ofsolution S. Solution S is clear ( )andcolourless ( , Method II).Acidity or alkalinity. To a volume of solution Scorresponding to 4 per cent of the nominal capacity ofthe container add ml ofphenolphthalein solution solution is colourless.

6 Add ml M sodiumhydroxide. The solution is pink. Add ml Mhydrochloric acidand ml ofmethyl red solution is orange-red or ( ). Measure the absorbance of solution Sfrom 230 nm to 360 nm, using the blank (see solution S)as the compensation liquid. At these wavelengths, theabsorbance is not greater than sulphuric acid Rand ml M potassiumpermanganate. Boil for 3 min. Cool immediately. Add 1 gofpotassium iodide Rand titrate immediately Msodium thiosulphate, using ml ofstarch solution Rasindicator. Carry out a titration using ml of the Fill a container previously used for thepreparation of solution S with a volume equal to the nominalcapacity of the primary opalescent suspension ( )diluted1in200foracontainermadefrompolye thyleneor polypropylene and 1 in 400 for other CONTAINERS .

7 Thecloudiness of the suspension is perceptible when viewedthrough the container and compared with a similar containerfilled withwater label accompanying a batch of empty CONTAINERS includesastatementof: the name and address of the manufacturer, a batch number which enables the history of the containerand of the PLASTIC material of which it is manufacturedto be STERILE PLASTIC CONTAINERSFOR HUMAN BLOOD ANDBLOOD COMPONENTSP lastic CONTAINERS for the collection, storage, processingand administration of blood and its components aremanufactured from one or more polymers, if necessarywith additives. The composition and the conditions ofmanufacture of the CONTAINERS are registered by theappropriate competent authorities in accordance with therelevant national legislation and international the composition of the materials of the differentparts of the CONTAINERS correspond to the appropriatespecifications, their quality is controlled by the methodsindicated in those specifications ( Materials used forthe manufacture of containersand subsections).

8 GeneralNotices(1)applytoallmonographsand othertexts379